Safety assessment of newly marketed herbal medicines--methodological approach (Ginkgo biloba example in Bulgaria).
This study presents a proposal for the methodological approach for postmarketing safety profile assessment based on sales data and information for adverse drug reactions of newly introduced herbal medicinal products in the market. The study covers all herbal medicinal products containing dry extract of Ginkgo biloba leaves allowed for sale in Bulgaria. The methodological approach we create should be used for the establishment of the national herbal drugs policy complying with the recent European regulatory changes and specificity of the therapeutic practice in the country.
Getov
Ilko N
IN
Faculty of Pharmacy, Medical University, Sofia, Bulgaria.
Tzenova
Alexandra Tv
AT
Ristoff
Mile S
MS
Todorov
Toncho V
TV
Petrova
Guenka I
GI
D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence* / Q000592:standards; D002031:Bulgaria; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005062:European Union; D020441:Ginkgo biloba; D006291:Health Policy; D029001:Herbal Medicine / Q000331:legislation & jurisprudence* / Q000592:standards; D006801:Humans; D008517:Phytotherapy / Q000592:standards*; D010936:Plant Extracts; D000096983:Ginkgo Extract
D010936:Plant Extracts; C063170:Ginkgo biloba extract; D000096983:Ginkgo Extract